A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

Ulcerative Colitis Clinical Trial

— ASSIST  

Official title:

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With Inflammatory Bowel DiSease Therapy-ASSIST Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316584
• Other study ID #: 22010339
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: University of Maryland, Baltimore
• Contact: Raymond K Cross, MD
• Phone: 410-706-3387
• Email: rcross[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization.

The investigators will address the following specific aims:

1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care.

2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care.

Description:

The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease (IBD) initiating oral or subcutaneous treatment. The investigators are conducting a 12-month multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization.

Adult participants with IBD with regular access to a mobile device or tablet initiating therapy with an oral or subcutaneous treatment for IBD at one of the five sites will be eligible to participate. Participants will be randomized 2:1 to the intervention or standard care. Eligible participants will complete an informed consent and baseline survey gathering demographic and clinical information.

TapptTM digital health system (developed by Synchronyx) is a remote therapeutic monitoring and digital engagement solution that monitors real-time medication adherence patterns through smart label technologies, capture patient reported outcomes (PROs) and barriers to care, and process patient data through algorithms that trigger personalized digital and human touchpoints between clinical visits. The research team will input information into the system on the intervention participant's medication to be tracked, dose, and frequency of dosing. Participants in the intervention group will be shipped the smart labels to be affixed to the pill bottle, pen, or syringe of the newly prescribed medication. Prior to receiving their medication, participants will receive virtual training on how to attach and use the proprietary labels, set up their participant profile, use the participant-facing web app, and seek technical helpdesk support. At the time of a medication dose, participants will scan the label by tapping it with their mobile device to verify that they are taking the medication. Upon scanning, participants immediately will receive a notification on their device indicating that the label was successfully scanned, and that their medication adherence was updated in their profile. The app offers participants visibility into their medication adherence patterns and upcoming doses, as well as the opportunity to respond to in-app questions that capture barriers towards adherence, IBD symptoms, and patient report outcomes (PROs). This information will also be available to the research and clinical team in real-time via the provider dashboard. Most importantly, the dashboard's artificial intelligence-based algorithm will send email alerts to the clinical team if participant's adherence, symptoms, or PROs fall below predetermined thresholds. For oral medications, mean adherence <86% in a 2-week period will trigger an alert. For SC medications, an alert will be generated if a dose is 10 days late for administration. A PRO 2 score for UC or CD of 2 or more will trigger an alert. If alerts are triggered for non-adherence, a clinical nurse, pharmacist, or social worker will contact the participant to identify barriers to adherence; remediation will be initiated if possible.

The primary outcome of the proposed study will be the difference in mean medication possession ratio (MPR) between the intervention and control group during the 12-month study. Secondary outcomes will include self-reported adherence (MARS-5), clinical response and remission (Harvey Bradshaw Index for CD and partial Mayo score of UC), steroid-free response and remission, PROMIS measures of Fatigue, Sleep Disturbance, Pain Interference, Anxiety, Depression, and Quality of Life, self-efficacy (IBD Self-Efficacy Scale), new steroid use, and health care utilization (urgent care or emergency room visit, unplanned office visit, hospitalization, and/or surgery).

Assuming 2 intervention participants for every 1 control with an adherence rate among controls of 0.65 and 0.9 in intervention participations with a Type 1 error rate of 0.05 and power of 0.9, we will need to enroll 82 intervention participants and 41 controls (n=123). All analyses will be completed using intention to treat principles. For categorical variables, the groups will be compared using the Chi Square test (Fisher's Exact if not normally distributed). For continuous variables, the groups will be compared using t tests (Wilcoxon signed rank if not normally distributed). We will also build logistic and linear regression models to adjust for confounding variable for the outcomes of interest. Possible confounding variables include but are not limited to route of administration, gender, insurance type, disease type, age, concurrent psychiatric disease, smoking, and concurrent steroid and/or narcotic use.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. At least 18 years of age or older

2. Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology

3. Initiating treatment with a new oral or subcutaneous treatment for IBD

4. Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access

5. Ability to understand the protocol and provide informed consent in English

Exclusion Criteria:

1. Inability to speak and read English

2. Inability to comply with the study protocol

3. Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis

4. Patients initiating oral corticosteroids only (without concurrent use of an oral or subcutaneous maintenance therapy)

5. Imminent surgery (within the next 60 days)

6. History of short bowel syndrome

7. Uncontrolled medical or psychiatric disease at the opinion of the investigator

1. Degenerative neurologic condition

2. Unstable angina

3. Symptomatic peripheral vascular disease

4. Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin)

5. Poorly controlled depression, mania, and schizophrenia

6. Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Behavioral:
• Remote monitoring
See prior description of the intervention.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York University	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	New York University, Synchronyx, LLC, University of Cincinnati, University of North Carolina, Chapel Hill, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	Medication possession ratio	1 year
Primary	Self-reported medication adherence	MARS-5, scores from 5 to 25 with higher scores indicated greater adherence	1 year
Secondary	Healthcare utilization	Rates of healthcare utilization including office and ER visits, hospitalizations, and diagnostic testing	1 year
Secondary	IBD Disease activity	Harvey Bradshaw Index ( for participants with Crohn's disease only), minimum score 0, no maximum score, higher scores indicated greater disease activity	1 year
Secondary	IBD Disease activity (objective)	C reactive protein, minimum value 0, no maximum value, higher values indicate greater disease activity	1 year
Secondary	Patient Reported Outcomes, Quality of Life	PROMIS Global Health, T scores from 0-100, 50 is the population mean, higher scores indicate better quality of life	1 year
Secondary	Self-efficacy	IBD Self-efficacy scale, scores range from 29-290 with higher scores indicated greater self-efficacy	1 year
Secondary	IBD Disease Activity	Simple clinical colitis activity index (participants with ulcerative colitis only), minimum score 0, maximum score 19, higher scores indicate greater disease activity	1 year
Secondary	IBD Disease Activity (objective)	Fecal calprotectin, minimum value 0, no maximum value, higher values indicate greater disease activity	1 year
Secondary	IBD Disease Activity (objective)	Mayo Endoscopic score (participants with ulcerative colitis only), minimum score 0, maximum score 3, higher scores indicate greater disease activity	1 year
Secondary	IBD Disease Activity (objective)	Simple endoscopic score (participants with Crohn's disease only), minimum score 0, maximum score 60, higher scores indicate greater disease activity	1 year
Secondary	Patient Reported Outcome (Pain interference)	PROMIS Pain Interference, T scores from 0-100, 50 is the population mean, higher scores indicate more pain	1 year
Secondary	Patient Reported Outcome (Anxiety)	PROMIS Anxiety, T scores from 0-100, 50 is the population mean, higher scores indicate more anxiety	1 Year
Secondary	Patient Reported Outcome (Depression)	PROMIS Depression, T scores from 0-100, 50 is the population mean, higher scores indicate more depression	1 year
Secondary	Patient Reported Outcome (Fatigue)	PROMIS Fatigue, T scores from 0-100, 50 is the population mean, higher scores indicate more fatigue	1 year
Secondary	Patient Reported Outcome (Sleep Disturbance)	PROMIS Sleep Disturbance, T scores from 0-100, 50 is the population mean, higher scores indicate more sleep disturbance	1 year